Another Whack at Biomedical Research Conflicts

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Sen. Charles Grassley isn't on the U.S. Senate Appropriations Committee. But that hasn't stopped the Iowa Republican from prodding Congressional budget setters to join his campaign to rein in perceived conflicts of interest in biomedical research, which they did with gusto Thursday.

As the full Senate appropriations panel embraced without major change legislation drafted earlier this week by a subcommittee to finance the Departments of Education, Labor and Health and Human Services in 2009, Grassley was not among the 30-odd senators in the room. But the actions they took were fully consistent with his recent push to ensure that federal and university officials are fully aware of the extent of financial and other relationships between academic researchers and pharmaceutical and other companies that fund research. (Grassley has harshly criticized researchers at the University of Cincinnati and Harvard University, and this week he turned his gaze on yet another psychiatrist, this time at Stanford University.)

The committee's original bill, which the panel has not yet released to the public, did not address the subject, but the accompanying report contained language that, in no uncertain terms, encouraged officials at the National Institutes of Health to address the problem of conflicts of interest. "Troubling allegations that some NIH-funded investigators have flaunted their universities' conflict of interest rules have recently come to light, and it seems clear that the NIH currently has no ability to monitor or prevent such abuses," the appropriations report said. "Moreover, up to this point the NIH leadership has not demonstrated much interest in dealing with the issue. That must change.

"The committee believes that the director has no higher priority in the coming year than to address this situation and fix it."

In a letter Wednesday to Sens. Robert Byrd (D-W.V.) and Thad Cochran (R-Miss.), the chairman and senior Republican, respectively, on the full Appropriations Committee, Grassley suggested that the Senate appropriations panel go further. "NIH oversight of the extramural program is lax, creating a $24 billion problem," Grassley wrote. "I am asking you to join me in holding the NIH accountable until it addresses this issue in a prompt and complete manner. Accordingly, I am suggesting that as part of the appropriations process, language be considered ensuring that the NIH is fully apprised of any conflicts existing among those individuals receiving NIH funds."

At Thursday's markup of the legislation, Sen. Wayne Allard, a Colorado Republican, offered an amendment that would have directed the NIH's director, Elias Zerhouni, to begin the process of soliciting opinion about how to draft new rules to govern potential conflicts of interest among NIH-funded scientists at colleges and universities. "I want to assure that they begin to modify [regulations for monitoring] extramural research and keep Congress informed," said Allard.

The lawmakers shepherding the education and health spending bill through the legislative process, Sens. Tom Harkin (D-Iowa) and Arlen Specter (R-Pa.), offered their own "friendly" alternative to Allard's proposal that would push the envelope even farther and crank up government scrutiny. Their proposal, which may still be tweaked as it moves through the legislative process, would require the Department of Health and Human Services (of which NIH is a part) to begin, within six months of the law's passage, a process of negotiated rule making that would lead to new (and presumably tougher) regulations on conflicts of interest in NIH-funded research.

"Our substitute amendment takes a little more comprehensive view," said Harkin. Allard's amendment, he said, "wouldn't require NIH to do anything," with the responsibility for monitoring conflicts of interest "borne entirely by the academic institutions that employ the scientists. The NIH provides the funds, so it ought to have a role in their oversight."

Other than the amendment on conflicts of interest, the bill the full Senate panel approved mirrors the version passed Tuesday by the appropriations subcommittee. It would provide $30.2 billion in funds for the NIH in the 2009 fiscal year, and increase the maximum Pell Grant by $69, leaving most other student aid programs flat.

Thursday was supposed to be a day when appropriations panels in both houses approved their spending bills for education, health and labor programs, but the House spending panel hit a major partisan roadblock. Frustrated by the panel's delay in taking up the spending bill for the Department of the Interior -- through which lawmakers hoped to provide some relief for Americans on gas prices by approving offshore drilling for oil -- the Republican leader of the House Appropriations Committee, Rep. Jerry Lewis of California, engaged in a parliamentary procedure in which he sought to replace the health and education bill with the Interior measure.

The ploy infuriated Rep. Dave Obey of Wisconsin, the Democrat who heads the spending panel. "It's stunts like this that make people hate Washington," Obey said, calling for adjournment of the committee and threatening to shut down the appropriations process.